July 16 Quick Takes: ROCK brings Kadmon first win at FDA; plus Merck, Moderna, Alexion, HIFs and more  

The first approval for Kadmon Holdings Inc. (NYSE:KDMN) — Rezurock belumosudil for third-line chronic graft-versus-host disease (cGVHD) — marks FDA’s first approval of a small molecule ROCK2 inhibitor. The approval, completed under Project Orbis and FDA’s Real-Time Oncology Review pilot program, came six weeks ahead of the drug’s Aug. 30 PDUFA date.

Prevnar 20 from Pfizer Inc. (NYSE:PFE) will have company on the market after FDA approved Vaxneuvance pneumococcal 15-valent conjugate vaccine from Merck & Co. Inc. (NYSE:MRK). Merck’s vaccine is indicated to prevent invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in those 18 years of age and older.  CDC’s Advisory Committee on Immunization Practices (ACIP) will meet in October to discuss and update recommendations on adult immunizations with pneumococcal vaccines...